Antarctic Krill Oil for Knee Osteoarthritis Pain
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45-75
SponsorQilu Hospital of Shandong University
About this trial
The goal of this clinical trial is to evaluate the effectiveness and safety of Antarctic Krill Oil (AKO) as a dietary supplement in managing pain associated with knee osteoarthritis (OA). The main questions it aims to answer are:
①Does AKO reduce daily pain intensity in participants with moderate knee OA?
②What adverse effects do participants experience when taking AKO?
Researchers will conduct a randomized, double-blind study comparing AKO to a placebo (identical appearance without active components) to assess:
* Changes in joint pain severity; ②Functional improvement in daily activities; ③Biochemical safety parameters,etc.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 45-75 years；
Clinically diagnosed with knee osteoarthritis per the Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 edition) issued by the Chinese Medical Association, with Kellgren-Lawrence grade 1-3；
Knee pain Visual Analog Scale (VAS) score between 4.0 and 8.0；
Ability to comprehend and complete VAS and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessments；
Disqualifiers
Ipsilateral hip osteoarthritis;
Diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis, sarcoidosis, amyloidosis, or any other inflammatory arthritis (e.g., gout, pseudogout);
Chronic pain syndromes, fibromyalgia, or comorbidities that may confound knee pain assessment;
Pain intensity in the lower extremities or back equal to or greater than knee pain;
Trial design
Design model
Parallel
Treatments tested in this trial
Krill oil
DrugAntarctic krill oil was used for intervention in the experimental group.
Olive Oil
Dietary supplementOlive oil was used for intervention in the placebo group.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Olive oilPlacebo comparator 1 intervention
Group B: Antarctic krill oilExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analogue Pain Scale
Joint pain severity was assessed using the Visual Analogue Scale (VAS).
Time frame
Baseline and week 24 after treatment initiation2
Adverse Reactions
Safety assessment of the treatment requires written documentation of adverse reactions, including their time of occurrence, frequency, and severity grading.
Time frame
Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation3
Serious Adverse Reactions
Safety assessment of the treatment requires written documentation of serious adverse reactions, including their time of occurrence, frequency, and severity grading.
Time frame
Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiationSecondary outcomes
1
WOMAC Pain Subscale
Joint pain severity was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.
Time frame
Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation2
WOMAC Stiffness Subscale
Degree of joint stiffness was evaluated with the WOMAC Stiffness Subscale.
Time frame
Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation3
WOMAC Physical Function Subscale
Joint functional ability was measured by the WOMAC Physical Function Subscale.
Time frame
Baseline, weeks 4, 8, 12, 16, 20, and 24 after treatment initiation4
Volume of Joint Effusion
To measure the volume of joint effusion, magnetic resonance imaging is used to scan the joint area and calculate the amount of effusion.
Time frame
Baseline, weeks 12 and 24 after treatment initiationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: